PURPOSE: The short-term toxicological effects of two cyclosporine A eyedrop formulations are compared. METHODS: Formula A was based on Sandimmune (Novartis, Switzerland) infusion concentrate with a final ethanol concentration of 1% (w/w), and formula B on Sandimmune oral solution. Both formulations were diluted in sterile peanut oil (10 mg/ml). The left eyes of 12 rabbits were treated with the cyclosporine eyedrops over a two-week period. The right eyes served as controls. Slit-lamp and scanning electron microscopic examinations were performed, and the total protein concentration in aqueous humor was measured in treated and control eyes. RESULTS AND CONCLUSION: Both Sandimmune oral solution and infusion concentrate-derived eyedrops were found to be non-toxic to rabbit eyes and there were no significant differences between the two formulations. More definite conclusions as to the safety of these cyclosporine formulations cannot be made without long-term trials.
PURPOSE: The short-term toxicological effects of two cyclosporine A eyedrop formulations are compared. METHODS: Formula A was based on Sandimmune (Novartis, Switzerland) infusion concentrate with a final ethanol concentration of 1% (w/w), and formula B on Sandimmune oral solution. Both formulations were diluted in sterile peanut oil (10 mg/ml). The left eyes of 12 rabbits were treated with the cyclosporine eyedrops over a two-week period. The right eyes served as controls. Slit-lamp and scanning electron microscopic examinations were performed, and the total protein concentration in aqueous humor was measured in treated and control eyes. RESULTS AND CONCLUSION: Both Sandimmune oral solution and infusion concentrate-derived eyedrops were found to be non-toxic to rabbit eyes and there were no significant differences between the two formulations. More definite conclusions as to the safety of these cyclosporine formulations cannot be made without long-term trials.
Authors: Arno Hueber; Johannes M Esser; Norbert Kociok; Gerhard Welsandt; Christoph Lüke; Sigrid Roters; Peter J Esser Journal: Graefes Arch Clin Exp Ophthalmol Date: 2007-10-13 Impact factor: 3.117
Authors: Rohan Bir Singh; Lingjia Liu; Ann Yung; Sonia Anchouche; Sharad K Mittal; Tomas Blanco; Thomas H Dohlman; Jia Yin; Reza Dana Journal: Ocul Surf Date: 2021-05-15 Impact factor: 6.268